Imaging With a PET Agent for Detection of Cancers of the Head and Neck

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-10

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to test the safety of a study drug called PARPi-FL. This drug has been tested in animals but not yet in people. The purpose of this study is to test if a PARPi-FL scan can be used to take pictures of head and neck cancer. The usual approach to imaging this cancer includes several different imaging scans, including x-rays, CT (computed tomography), MRI (magnetic resonance imaging), and PET (positron emission tomography). These tests take pictures of the cancer.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PET and MRI Imaging of Brain Tumors Using [18F]PARPi

NCT04173104

Brain Tumor Brain Cancer

ACTIVE_NOT_RECRUITING EARLY_PHASE1

Comparing an Investigational Scan (F-18 NaF PET/CT) to Standard of Care Imaging (F-18 FDG PET/CT) for Evaluating Vascular Complications in Patients Receiving Radiation Therapy for Head and Neck Cancer

NCT06914999

Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 +13 more

RECRUITING EARLY_PHASE1

Molecular Imaging of DNA Damage Response by [18F]-Olaparib PET

NCT06482307

Head and Neck Squamous Cell Carcinoma (HNSCC)

NOT_YET_RECRUITING PHASE1/PHASE2

A Proof-of-concept Study to Assess the Ability of [18F]AH-111585 PET Imaging to Detect Tumours and Angiogenesis

NCT00565721

High-grade Glioma Lung Cancer Head & Neck Cancer +2 more

COMPLETED PHASE2

F-18 Fluorothymidine PET Imaging for Early Evaluation of Response to Therapy in Head & Neck Cancer Patients

NCT00721799

Mouth Neoplasms Oropharyngeal Neoplasms Laryngeal Neoplasms +1 more

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head and Neck Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This is an open label, investigator initiated single arm, first in human study of a PARP1/2 imaging agent in patients with head and neck squamous cell carcinomas scheduled to undergo surgery.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Phase I: [18 F]-PARPi and PET/CT Scans

The intervention of this study is the injection of a microdose (\< 10 0 ug) of \[18 F\]- PARPi followed by 3 PET/CT studies to determine the biodistribution of this imaging agent in normal organs as well as the kinetics of uptake in squamous cell carcinomas of the head and neck.

Group Type EXPERIMENTAL

[18F]- PARPi

Intervention Type DRUG

injection of a microdose (\< 100 ug) of \[18F\]- PARPi

PET/CT Scans

Intervention Type DIAGNOSTIC_TEST

Patients will be injected with approximately 10 mCi of \[18F\]PARPi and a dynamic PET scan of will be acquired for approximately 30 minutes. A second body PET/CT scan will be started approximately 60 min post injection, and a third PET/CT scan will be started at approximately 120 min post injection. The first (dynamic) and the second (body) PET/CT scan will use "ultra -low dose" CT scan for attenuation correction. The last PET/CT scan will be performed with the investigator's regular clinical low-dose CT settings.

Phase II: [18 F]-PARPi and PET/CT Scans

The intervention of this study is the injection of a microdose (\< 10 0 ug) of \[18 F\]- PARPi followed by 3 PET/CT studies to determine the biodistribution of this imaging agent in normal organs as well as the kinetics of uptake in squamous cell carcinomas of the head and neck.

Group Type EXPERIMENTAL

[18F]- PARPi

Intervention Type DRUG

injection of a microdose (\< 100 ug) of \[18F\]- PARPi

PET/CT Scans

Intervention Type DIAGNOSTIC_TEST

Patients will be injected with approximately 10 mCi of \[18F\]PARPi and a dynamic PET scan of will be acquired for approximately 30 minutes. A second body PET/CT scan will be started approximately 60 min post injection, and a third PET/CT scan will be started at approximately 120 min post injection. The first (dynamic) and the second (body) PET/CT scan will use "ultra -low dose" CT scan for attenuation correction. The last PET/CT scan will be performed with the investigator's regular clinical low-dose CT settings.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

[18F]- PARPi

injection of a microdose (\< 100 ug) of \[18F\]- PARPi

Intervention Type DRUG

PET/CT Scans

Patients will be injected with approximately 10 mCi of \[18F\]PARPi and a dynamic PET scan of will be acquired for approximately 30 minutes. A second body PET/CT scan will be started approximately 60 min post injection, and a third PET/CT scan will be started at approximately 120 min post injection. The first (dynamic) and the second (body) PET/CT scan will use "ultra -low dose" CT scan for attenuation correction. The last PET/CT scan will be performed with the investigator's regular clinical low-dose CT settings.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Part 1:

* Age ≥18 years
* ECOG performance status 0 or 1
* Biopsy (histologically or cytologically) proven Squamos Cell Carcinoma
* Oral cavity, oropharynx, or nasopharynx primary site
* At least one tumor lesion on standard of care imaging with a minimum diameter of at least 1.5 cm
* Scheduled to undergo treatment at MSKCC
* Willingness to sign informed consent

Part 2

* Age ≥18 years
* ECOG performance status 0 or 1
* Biopsy (histologically or cytologically) proven Squamous Cell Carcinoma
* Oral cavity,oropharynx, or nasopharynx primary site
* Scheduled to undergo surgery (neck dissection and/ or neck dissection + surgical removal of the primary) at MSK
* Willingness to sign informed consent
* Should have had a standard-of-care \[18F\]-FDG PET/CT scan before surgery (to minimize the possibility of new alterations developing between the two scans both scans should be acquired within a maximum time difference of one month).

Exclusion Criteria

* Significantly impaired organ function that may interfere with the excretion and metabolism of the imaging agent. Specifically, patients will be excluded if they meet the following criteria:
* Hematologic

o Platelets \<75K/mcL
* Hepatic

* Bilirubin \>2.0 x ULN (institutional upper limits of normal)
* AST/ALT \>2.5 x ULN
* Renal

o Creatinine \> 2.0 x ULN
* Claustrophobia interfering with PET/CT imaging

* Known allergy to PEG300
* Pregnancy or breastfeeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No